Back to resultsBioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HL068 16/10mg
Candesartan 16mg and Amlodipine 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteer in the age between 19 and 55 years old.
- Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
- Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria:
- Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
- History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit
- Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
- Participation in any clinical investigation within 3 months prior to study drug administration
- Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
- SBP ≥ 140 mmHg or< 115 mmHg, DBP ≥ 90 mmHg or < 70 mmHg
- Caffeine > 400mg/day
- Alcohol > 30g/day
- Cigarette > 10 cigarettes/day.
- Subjects who are judged unsuitable by investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Candesartan 16mg and Amlodipine 10mg
HL068
Arm Description
Candesartan 16mg and Amlodipine 10mg
HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)
Outcomes
Primary Outcome Measures
AUCt
Cmax
Secondary Outcome Measures
AUCinf
Tmax
t 1/2β
CL/F
Full Information
NCT ID
NCT02988362
First Posted
December 7, 2016
Last Updated
December 8, 2016
Sponsor
HanAll BioPharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02988362
Brief Title
Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
Official Title
An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HanAll BioPharma Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Candesartan 16mg and Amlodipine 10mg
Arm Type
Experimental
Arm Description
Candesartan 16mg and Amlodipine 10mg
Arm Title
HL068
Arm Type
Experimental
Arm Description
HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)
Intervention Type
Drug
Intervention Name(s)
HL068 16/10mg
Intervention Description
Candesartan 16mg and Amlodipine 10mg
Intervention Type
Drug
Intervention Name(s)
Candesartan 16mg and Amlodipine 10mg
Primary Outcome Measure Information:
Title
AUCt
Time Frame
up to 72 hours
Title
Cmax
Time Frame
up to 72 hours
Secondary Outcome Measure Information:
Title
AUCinf
Time Frame
up to 72 hours
Title
Tmax
Time Frame
up to 72 hours
Title
t 1/2β
Time Frame
up to 72 hours
Title
CL/F
Time Frame
up to 72 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteer in the age between 19 and 55 years old.
Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria:
Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit
Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
Participation in any clinical investigation within 3 months prior to study drug administration
Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
SBP ≥ 140 mmHg or< 115 mmHg, DBP ≥ 90 mmHg or < 70 mmHg
Caffeine > 400mg/day
Alcohol > 30g/day
Cigarette > 10 cigarettes/day.
Subjects who are judged unsuitable by investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Ran Yoon, M.D, Ph.D
Organizational Affiliation
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32656160
Citation
Lee HW, Kang WY, Jung W, Gwon MR, Yang DH, Kim EH, Cho K, Yoon YR, Seong SJ. Pharmacokinetics and bioequivalence of fixed-dose combination of candesartan cilexetil/amlodipine besylate (16/10 mg) versus coadministration of individual formulations in healthy subjects. Transl Clin Pharmacol. 2020 Jun;28(2):92-101. doi: 10.12793/tcp.2020.28.e8. Epub 2020 Jun 24.
Results Reference
derived
Learn more about this trial
Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
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